USING BIOLOGICALS AND ANIMALS PROCEDURE AS/NZS 4801 OHSAS 18001 OHS20309 SAI Global November 2015 CONTENTS 1. PURPOSE ................................................................................................................................................. 3 2. SCOPE ...................................................................................................................................................... 3 3. ABBREVIATIONS ..................................................................................................................................... 3 4. DEFINITIONS ............................................................................................................................................ 3 4.1 4.2 4.3 4.4 4.5 4.6 4.7 5. SPECIFIC RESPONSIBILITIES ................................................................................................................ 5 5.1 5.2 5.3 5.4 5.5 5.6 5.7 6. ANIMALS ............................................................................................................................................................................................................ 3 BIOLOGICALS .................................................................................................................................................................................................... 4 BIOLOGICAL WASTES ...................................................................................................................................................................................... 4 GENE TECHNOLOGY ....................................................................................................................................................................................... 4 GENETICALLY MODIFIED ORGANISM ........................................................................................................................................................... 4 (MATERIAL) SAFETY DATA SHEET ................................................................................................................................................................. 5 ORGANISM ........................................................................................................................................................................................................ 5 OCCUPATIONAL HEALTH & SAFETY (OH&S) ................................................................................................................................................ 5 RESEARCH OFFICE .......................................................................................................................................................................................... 5 MONASH ANIMAL ETHICS OFFICE ................................................................................................................................................................. 5 HEADS OF ACADEMIC/ADMINISTRATIVE UNITS .......................................................................................................................................... 5 SUPERVISORS .................................................................................................................................................................................................. 5 BIOSAFETY OFFICERS .................................................................................................................................................................................... 6 STAFF AND STUDENTS.................................................................................................................................................................................... 6 FACILITIES & SAFE WORK PRACTICES FOR WORK WITH BIOLOGICALS ....................................7 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 6.11 6.12 6.13 6.14 TYPES OF FACILITIES ...................................................................................................................................................................................... 7 CONTAINMENT LEVELS UNDER THE AS/NZS 2243.3 .................................................................................................................................. 7 PC1 LABORATORY FACILITIES ...................................................................................................................................................................... 7 PERSONAL PROTECTIVE CLOTHING AND EQUIPMENT ............................................................................................................................. 7 WORK PRACTICES ........................................................................................................................................................................................... 8 PC2 LABORATORY ........................................................................................................................................................................................... 8 FACILITIES ......................................................................................................................................................................................................... 8 CONTAINMENT EQUIPMENT ........................................................................................................................................................................... 8 PERSONAL PROTECTIVE EQUIPMENT ......................................................................................................................................................... 8 WORK PRACTICES ........................................................................................................................................................................................... 8 PC3 LABORATORY ........................................................................................................................................................................................... 9 FACILITIES ......................................................................................................................................................................................................... 9 CONTAINMENT EQUIPMENT ........................................................................................................................................................................... 9 WORK PRACTICES ........................................................................................................................................................................................... 9 7. HUMAN CLINICAL SAMPLES ...............................................................................................................10 8. MICRO-ORGANISMS .............................................................................................................................10 8.1 8.2 9. RISK GROUPS ................................................................................................................................................................................................. 10 FACILITIES ....................................................................................................................................................................................................... 10 ANIMALS ................................................................................................................................................10 9.1 9.2 9.3 9.4 9.5 9.6 FACILITIES ....................................................................................................................................................................................................... 10 TRANSGENIC OR KNOCKOUT ANIMALS ..................................................................................................................................................... 11 OCCUPATIONAL HEALTH .............................................................................................................................................................................. 11 LABORATORY ANIMAL ALLERGY (LAA) ....................................................................................................................................................... 11 ZOONOSIS ....................................................................................................................................................................................................... 12 INFECTIOUS ANIMAL MODELS ..................................................................................................................................................................... 13 10. HEALTH SURVEILLANCE .....................................................................................................................13 11. IMMUNISATION ......................................................................................................................................13 12. IMPORTATION OF BIOLOGICALS .......................................................................................................13 12.1 QUARANTINE REQUIREMENTS..................................................................................................................................................................... 13 Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 1 of 27 Date of next review: 2018 19/11/15 12.2 12.3 12.4 13. GENETICALLY MODIFIED ORGANISMS..............................................................................................14 13.1 13.2 14. WORK/STUDY WITH GMO .............................................................................................................................................................................. 14 FACILITIES ....................................................................................................................................................................................................... 14 (M)SDS ....................................................................................................................................................14 14.1 15. PURCHASE OF BIOLOGICALS ...................................................................................................................................................................... 13 PERMITS .......................................................................................................................................................................................................... 14 FACILITIES ....................................................................................................................................................................................................... 14 HAZARDOUS MATERIAL ................................................................................................................................................................................ 14 RISK MANAGEMENT .............................................................................................................................15 15.1 15.2 RISK MANAGEMENT MUST BE COMPLETED .............................................................................................................................................. 15 UPDATE AND REVIEW OF RISK ASSESSMENTS ........................................................................................................................................ 15 16. SAFE WORK INSTRUCTIONS ...............................................................................................................15 17. TRAINING ...............................................................................................................................................15 17.1 17.2 17.3 17.4 17.5 18. WASTE DISPOSAL ................................................................................................................................17 18.1 19. BIOLOGICAL SAFETY ..................................................................................................................................................................................... 15 LOCAL TRAINING ............................................................................................................................................................................................ 15 UNIVERSITY LEVEL TRAINING ...................................................................................................................................................................... 16 ANIMAL CARE AND USE ................................................................................................................................................................................ 16 TRAINING RECORDS ...................................................................................................................................................................................... 16 ALL BIOLOGICAL WASTE MUST BE.............................................................................................................................................................. 17 EMERGENCIES INVOLVING BIOLOGICALS AND ANIMALS .............................................................18 19.1 19.2 INCIDENT AND EMERGENCY RESPONSE ................................................................................................................................................... 18 CRISIS MANAGEMENT ................................................................................................................................................................................... 18 20. RECORDS ...............................................................................................................................................18 21. REFERENCES ........................................................................................................................................19 21.1 21.2 21.3 21.4 LEGISLATION .................................................................................................................................................................................................. 19 MONASH UNIVERSITY OHS DOCUMENTS .................................................................................................................................................. 19 AUSTRALIAN AND INTERNATIONAL STANDARDS ..................................................................................................................................... 19 OTHER DOCUMENTS ..................................................................................................................................................................................... 20 22. DOCUMENT HISTORY ...........................................................................................................................21 23. APPENDIX I - EXAMPLES OF ZOONOTIC DISEASES ........................................................................22 24. APPENDIX II – RISK GROUP 2 ORGANISMS ......................................................................................23 24.1 24.2 24.3 24.4 25. EXAMPLES OF BACTERIA ............................................................................................................................................................................. 23 BACTERIA REQUIRING SPECIAL PRECAUTIONS ....................................................................................................................................... 24 EXAMPLES OF PARASITES (INFECTIVE STAGES ONLY) .......................................................................................................................... 24 EXAMPLES OF FUNGI .................................................................................................................................................................................... 24 APPENDIX III – RISK GROUP 3 ORGANISMS .....................................................................................27 25.1 25.2 25.3 BACTERIA ........................................................................................................................................................................................................ 27 FUNGI ............................................................................................................................................................................................................... 27 VIRUSES .......................................................................................................................................................................................................... 27 Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 2 of 27 Date of next review: 2018 19/11/15 1. PURPOSE The purpose of this document is to instruct staff, students, visitors and contractors who either use biologicals and/or animals or perform work in areas where biologicals and/or animals are used at Monash University to ensure that work is performed in accordance with the relevant legislative requirements. 2. SCOPE This document applies to all staff, students, visitors and contractors who either use biologicals and/or animals or perform work in areas where biologicals and/or animals are present at an Australian campuses of Monash University. 3. ABBREVIATIONS DoA Department of Agriculture, DNA Deoxyribonucleic acid EPA Environment Protection Agency GMO Genetically modified organism GT Gene Technology IBC Institutional Biosafety Committee LAA Laboratory Animal Allergy (M)SDS Material Safety Data Sheet OGTR Office of the Gene Technology Regulator OHS Occupational health and safety OH&S Occupational Health & Safety 4. PC Physical Containment QAP Quarantine Approved Premises SDU Staff Development Unit SWI Safe Work Instructions DEFINITIONS A comprehensive list of definitions is provided in the Definitions Tool. Definitions specific to this procedure are as follows. 4.1 ANIMALS An animal is defined as any multicellular heterotrophic eukaryote belonging to the Kingdom Animalia (vertebrates and invertebrates). Under the Prevention of Cruelty to Animals Act the following require Animal Ethics approval: • any live non-human vertebrate (fish, amphibians, reptiles, birds and mammals) encompassing domestic animals, purpose-bred animals, livestock, wildlife, as well as cephalopod invertebrates such as octopus, squid, cuttlefish and nautilus. • any live pre-natal or pre-hatched embryos, foeti and larval forms e.g. a mammalian or reptilian foetus, pre-hatched avian, mammalian or reptilian young and live marsupial young developed beyond half the gestation or Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 3 of 27 Date of next review: 2018 19/11/15 incubation period of the relevant species, or they become capable of independent feeding. • 4.2 This is not required for insects, millipedes, annelids (worms), gastropods (slugs and snails) or spiders, shellfish (bivalves, mussels, oyster and scallop); eggs, spat or spawn of fish. BIOLOGICALS For the purpose of this document, the definition of a biological will include, but not be limited to blood, blood products, tissue, body fluids (e.g. urine, faeces, semen, vaginal secretions, pericardial fluid, cerebrospinal fluid, synovial fluid, pleural fluid, amniotic fluid, saliva, mucus, any fluid with visible blood) and any derivatives produced by chemical or physical means (e.g. protein, enzyme or blood fractions). In addition, it is intended to cover micro-organisms (bacteria, viruses, parasites, fungi, prions) wildtype or mutant and plants and plant material. It is not intended to include live animals in this definition. 4.3 BIOLOGICAL WASTES These are covered by Environment Protection Agency (EPA) Regulations and are legally known as “clinical and related” or prescribed wastes and include: 4.4 • discarded sharps • laboratory and associated wastes directly involved in specimen processing • human and animal tissue, including materials or solutions containing or contaminated with blood or body fluids • cytotoxic wastes • pharmaceutical wastes and chemical wastes GENE TECHNOLOGY For the purpose of this document gene technology is defined as any technique for the modification of genes or other genetic material, but does not include sexual reproduction, homologous recombination or any other techniques specified in Part 2, Division 2 of the Gene Technology Act (2000). 4.5 GENETICALLY MODIFIED ORGANISM For the purpose of this document a genetically modified organism (GMO) is defined as: • an organism that has been modified by gene technology; • an organism that has inherited traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology; or • anything declared by the Gene Technology Regulations to be a genetically modified organism, or that belongs to a class of things declared by the Regulations to be genetically modified organisms. But does not include: • a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or • an organism declared by the Regulations not to be a genetically modified organism, or that belongs to a class of organism declared by the Regulations not to be genetically modified organisms. Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 4 of 27 Date of next review: 2018 19/11/15 4.6 (MATERIAL) SAFETY DATA SHEET A material safety data sheet is a document prepared by the manufacturer or importer of a biological which describes uses, chemical and physical properties, health hazard information, precautions for use, safe handling and emergency information. 4.7 ORGANISM For the purpose of this document an organism is defined as a biological entity that in at least some form is capable of response to stimuli, reproduction or transfer of genetic material, growth and development, and maintenance of homeostasis. 5. SPECIFIC RESPONSIBILITIES A comprehensive list of OHS responsibilities is provided in the document OHS Roles, Committees and Responsibilities Procedure. A summary of responsibilities with respect to this procedure is provided below. 5.1 OCCUPATIONAL HEALTH & SAFETY (OH&S) The responsibilities of OH&S include: 5.2 • development, maintenance, review and audit of the university's policies, • advising on appropriate immunisation; • procedures and systems related to biological safety management; providing information, management. instruction and training on biological safety RESEARCH OFFICE The responsibilities of the Research Office include: 5.3 • administering all matters relating to the Gene Technology Act 2000 (including the Gene Technology Regulations 2001) and Quarantine Act 1908 and theirdischarge. • providing information, instruction and training on work involving GMOs or biologicals subject to quarantine requirements. MONASH ANIMAL ETHICS OFFICE The responsibilities of the Monash Animal Ethics Office include: 5.4 • administering all ethical matters relating to the use of animals for research purposes. • providing information and instruction on regulatory issues, animal care and the Animal Ethics approval process. HEADS OF ACADEMIC/ADMINISTRATIVE UNITS It is the responsibility of the head of academic/administrative unit or controlled entity to ensure that procedures and systems are in place in their unit or entity to manage biological and/or animals effectively to ensure: 5.5 • a healthy and safe environment for staff, students, visitors and contractors; • that local standards and practices comply with legislative requirements and university policy; • that staff and students undertake recommended training in the use of biologicals and/or animals. SUPERVISORS It is the responsibility of supervisors to ensure that procedures and systems are in Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 5 of 27 Date of next review: 2018 19/11/15 place in the areas of their responsibility to manage biological and/or animals effectively to ensure: 5.6 5.7 • a healthy and safe environment for staff, students, visitors and contractors; • that local standards and practices comply with legislative requirements and university policy; • that staff and students undertake recommended training in the use of biological and/or animals. BIOSAFETY OFFICERS • It is the responsibility of the Biosafety Officer to: • advise, inform and instruct staff and students on the local use, storage, transport and disposal of biological substances, including appropriate equipment, facilities and work practices to prevent exposure to any harmful biological material and ensure appropriate containment ; • assist in local induction of new staff and students with regards to biosafety, OGTR and quarantine matters; • monitor the need and advise staff and students of availability and procedures for immunisation against potential biohazards; • serve as a local source of expertise to the unit/entity regarding biosafety, OGTR and quarantine requirements including licensing, certification of facilities and classification of activities under the relevant legislation and standards; • monitor local area compliance with biosafety, OGTR and quarantine requirements with regard to the use and disposal of hazardous biological materials and recombinant DNA molecules; • liaise with the university’s Research Compliance Officer, OH&S, local OHS committee, head of unit or controlled entity and local health & safety representative in matters relating to biosafety, OGTR and quarantine ; • review biosafety aspects of research projects and teaching activities and provide advice/assistance on document preparation, e.g. risk assessments, OGTR applications; • develop and implement emergency response procedures for incidents involving biohazardous agents and materials; • participate in workplace inspections of research and teaching facilities for compliance with regulations and guidelines pertaining to the use, handling, and disposal of potential biohazards and recombinant DNA; • respond to and investigate all biosafety incidents occurring within the department, and develop corrective action plans; • report any breach of compliance to the Research Compliance Officer (who will in turn notify the Institutional Biosafety Committee (IBC)) and OH&S; STAFF AND STUDENTS Staff using biological and/or animals must comply with OHS instructions, policies and procedures using control measures and/or personal protective equipment to ensure their own health and safety as well as the health and safety of others. Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 6 of 27 Date of next review: 2018 19/11/15 6. FACILITIES & SAFE WORK PRACTICES FOR WORK WITH BIOLOGICALS 6.1 6.2 TYPES OF FACILITIES 6.1.1 Facilities for the use of biologicals are defined by the Gene Technology Act, Australian Quarantine Act and Australian standards for laboratory design and construction (AS/NZS 2982) and Safety in the laboratory (AS/NZS 2243.3). 6.1.2 Facilities certified by the OGTR for research involving recombinant DNA technology are signed with OGTR stickers denoting the containment level. Facilities certified by Department of Agriculture (DoA) for research with imported materials are signed with Quarantine Approved Premises stickers. PC1 – PC4 facilities as defined by AS/NZS 2243.3 are not signed. CONTAINMENT LEVELS UNDER THE AS/NZS 2243.3 AS/NZS 2243.3 defines levels of Physical Containment (PC) for working with biologicals. At Monash University we have facilities that are classified into three such physical containment levels; PC1, PC2 and PC3. PC1 is the minimal level and describes most general laboratory areas including most teaching laboratories, whereas PC3 is the highest level at Monash and is required for work involving infectious pathogens. 6.3 6.4 PC1 LABORATORY FACILITIES • Emergency drench showers and eyewash stations shall be available at a distance of no more than 15 metres or within approximately 10 seconds travel time from any position in the laboratory. Where these facilities are not available alternate arrangements should be made in consultation with the OHS consultant/advisor for the area. • Bench tops shall be able to withstand heat generated by general laboratory procedures. • Chairs/stools shall be ergonomically suitable for the tasks and adjustable to work with the heights of benches and other equipment. The material shall be smooth and impervious to water to facilitate cleaning. • Wash basins with hot and cold water shall be provided inside each laboratory near the exit. • Open spaces between and under benches, cabinets and equipment shall be accessible for cleaning. • Write up areas must be separated from work/study areas to minimise the chance of reading and writing materials being contaminated or damaged. PERSONAL PROTECTIVE CLOTHING AND EQUIPMENT • Laboratory staff shall wear protective clothing when performing procedures in the laboratory. The use of long sleeved cotton or polyester wrap around gowns or laboratory coats is recommended. • Protective eyewear shall be worn by staff when working in the laboratory. Some procedures may require full face protection which will be assessed when performing risk assessments of the procedure. • Closed footwear shall be worn by staff when entering the laboratory. • The above three items are the minimum personal protective equipment requirements for a laboratory unless lesser requirements can be justified by a risk assessment. Contact your OHS consultant/advisor for assistance in assessing such risk. Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 7 of 27 Date of next review: 2018 19/11/15 6.5 6.6 WORK PRACTICES • Eating, drinking, shaving and the application of cosmetics is prohibited in laboratories. • Food and drink for consumption must not be stored in laboratories or laboratory refrigerators or freezers. • Long hair shall be tied back. • All hazardous work must be identified, assessed for their risk and controls implemented where necessary. PC2 LABORATORY The conditions for PC2 laboratories listed below are in conjunction with those for PC1 laboratories. 6.7 6.8 6.9 FACILITIES • The ceilings, walls and floors shall be smooth, easy to clean and impermeable to liquids, and resistant to commonly used reagents and disinfectants. • Hand wash basins shall be fitted with hands-free operation type mixers or suitable alternatives discussed with your OHS consultant/advisor. • A pressure steam sterilizer shall be available where steam sterilizing of infectious waste is required onsite. • Suitable coat hooks shall be provided near the entry/exit of the laboratory and lab coats shall be laundered regularly. • A supply of clearly labelled disinfectants for decontamination purpose shall be available. CONTAINMENT EQUIPMENT • Biological safety cabinets shall be used when working with specimens containing micro-organisms transmissible by the respiratory route or when work produces a significant risk from aerosol production. • Centrifuges that are used for human samples or infectious micro-organisms shall be fitted with either a sealed rotor or safety buckets. Samples should also be placed in sealable tubes. PERSONAL PROTECTIVE EQUIPMENT • 6.10 Suitable gloves shall be worn when handling human blood, body fluids or tissue, or micro-organisms or when working in biological safety cabinets. WORK PRACTICES • Access to PC2 laboratories shall be restricted to appropriately trained staff and students. • Staff and students shall receive instruction and training appropriate to the specimens handled. • Staff and students should attend Biosafety training (see Section 17). • Particular care should be taken when handling and disposing of any sharps to avoid accidental self- inoculation. • All clinical samples shall be treated as infectious. • All visitors to the laboratory including Facilities & Services staff must be inducted appropriately and shall be made aware of any specific hazards in the area. Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 8 of 27 Date of next review: 2018 19/11/15 6.11 • Any procedure which may produce aerosols of potentially infectious material shall be performed in a biological safety cabinet. • A container of viable micro-organisms shall be transported between facilities or to steam sterilizers in a sealed secondary unbreakable container which can be readily decontaminated. • All potentially contaminated equipment shall be either steam sterilized or chemically disinfected after use. • Separate report writing and long-term write up areas shall be provided outside the laboratory. PC3 LABORATORY The conditions for PC3 laboratories listed below are in conjunction with those for PC1 and PC2 laboratories. 6.12 6.13 6.14 FACILITIES • The laboratory must be separated from all other areas and shall not be accessible by the general public. • Entry to the laboratory shall only be through a double door airlock system. Doors shall be self-closing, open outwards with the outer door being lockable. Both doors shall be fitted with seals to limit air leakage. Doors shall contain glass viewing panels so that observation of the laboratory occupants may be possible. • All equipment used in a PC3 laboratory shall be decontaminated prior to maintenance, service or removal. • An emergency two-way communication system, or an alarm system, shall be provided in addition to the telephone. • A pressure steam sterilizer for decontamination of laboratory wastes shall be available and located within the laboratory. • Liquid effluents shall be discharged in a manner appropriate to the type of waste and as determined by the Risk assessment and in compliance with trade waste agreements. • Laboratory ventilation shall be set up to ensure a graduated negative pressure with the directional airflow moving inwards to the laboratory working area. The air handling shall be set up by specialist air handling engineers. CONTAINMENT EQUIPMENT • Where a central reticulated vacuum system or portable pumps are used, a 0.2 • µm hydrophobic membrane-type filter, and liquid disinfectant trap shall be installed at the point of use. • Where required, a class III biological safety cabinet shall be made available. WORK PRACTICES • Staff and students shall be trained in handling the specific pathogens used in the laboratory. • Laboratory door/s must be locked when unoccupied. • All work with risk group 3 organisms shall be conducted in a biological safety cabinet. • No one shall enter the laboratory for cleaning, servicing of equipment, repairs or other activities before relevant potentially contaminated laboratory surfaces Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 9 of 27 Date of next review: 2018 19/11/15 have been disinfected and authorisation has been obtained from the safety or biosafety officer. 7. 8. • Protective clothing shall not be worn outside of the laboratory and must be sterilised before laundering. • Outer clothing and personal effects shall not be taken into the laboratory. • An emergency evacuation plan shall be devised and made available to all staff and students working in the facility, OH&S and Monash Security staff. HUMAN CLINICAL SAMPLES • Human clinical samples are to be treated as potentially infectious unless categorically known to be otherwise. For that reason all clinical samples are to be used in facilities that meet pc2 facility and procedural requirements as described in section 6. However, if organisms from a higher risk group are isolated or suspected to be found in a clinical sample then the sample should be treated as per that risk group and used in a higher containment facility. • Procedures that will create significant aerosols must be performed in biological safety cabinets. MICRO-ORGANISMS 8.1 RISK GROUPS Micro-organisms are divided into risk groups 1 (lowest risk) – 4 (highest risk) based on their risk to health and safety. 8.2 • A list of risk group 2 and 3 organisms can be found in Appendix II and III. • The risk group classification has been established to match the physical containment level of the facility where the work is to be conducted, eg risk group 2 organisms must be handled in a PC2 facility. FACILITIES Facilities where work with micro-organisms is to be performed must meet the building requirements and procedural requirements for the physical containment level (Section 6) corresponding to the appropriate physical containment level of that microorganism. 9. ANIMALS The use of animals at Monash University must comply with all relevant Victorian and federal government legislation. For all ethical matters relating to the use of animals for research, contact the Monash Animal Ethics Office. 9.1 FACILITIES Facilities for the housing and care of laboratory animals are defined in the Victorian Code of Practice for Housing and Care of Laboratory Mice, Rats, Guinea Pigs and Rabbits and the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes and must meet the minimum standards as set out in the Prevention of Cruelty to Animals Act. All further queries should be referred to the Monash Animal Ethics Office. • Animals can be held in a variety of containment facilities that are designed to ensure that the animals, and the micro-organisms that may be being used in Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 10 of 27 Date of next review: 2018 19/11/15 conjunction with the animals, do not escape from containment. • 9.2 Whilst the general design is similar to that of laboratories (see section 6), one key consideration is that of primary containment to prevent crosscontamination and exposure of personnel to allergens and micro-organisms. Further details are outlined in AS/NZ 2243.3, section 6. TRANSGENIC OR KNOCKOUT ANIMALS The use of transgenic or knock out animals must meet the requirements of the OGTR as must the facilities where they are housed. General information regarding the use of GM animals and appropriate approval can be obtained from the OGTR website or by contacting the Research Office. 9.3 OCCUPATIONAL HEALTH It is important to be aware of the potential hazards and health risks associated with working with laboratory animals and to be aware of the precautions needed to prevent or adequately control exposure. The OHS Health team can be contacted f o r advice on any aspects of the health issues associated with working with animals. 9.4 LABORATORY ANIMAL ALLERGY (LAA) LAA is an allergic hypersensitivity response which may develop as a result of exposure to animal allergens. The proteins most commonly associated with allergic reactions are found in animal urine, saliva and dander. • Anyone who has regular contact with laboratory animals and/or associated materials, e.g. animal litter has the potential to develop allergies to the animals they are working with. • Early symptoms of LAA may include nasal congestion and sneezing, dry and sore throat, watering and itchy eyes, rashes and itchy skin, as well as cough with asthma-like symptoms. • Continued exposure, may increase the severity of symptoms and infrequently sensitisation may occur. This can pose a significant health risk and early contact with the OHS Health team is required. Although those workers who have a personal history of allergy to common environmental allergens (atopy) and exposure to animals are at increased risk, individuals with no prior history of allergies and only brief work exposures can also develop LAA. Most workers will do so within three years of working with animals. The best approach for reducing the likelihood of developing an allergic reaction is to eliminate or minimise exposure to the proteins found in animal urine, saliva, and dander. A comprehensive risk assessment and implementation of appropriate control measures should be undertaken prior to working with animals. Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 11 of 27 Date of next review: 2018 19/11/15 The follo Low Task Controls Working with post mortem or with tissues Wear appropriate personal protective equipment (lab coat, gloves, respiratory protection)1 Work on unconscious animals Adhere to safe work instructions Procedures involving few animals Assessment by Occupational Physician (case by case) Automated cage cleaning Medium Cleaning within animal unit Wear appropriate personal protective equipment (lab coat, gloves, respiratory protection)1 Indirect contact in animal room Assessment by Occupational Physician (case by case) Feeding Animals Participate in Health Surveillance program, e.g. lung function test Adhere to safe work instructions Reduce airborne allergens when cleaning cages, i.e. wet cleaning Use low dust bedding materials High Injections and other invasive procedures Wear appropriate personal protective equipment (lab coat, gloves, respiratory protection)1 Shaving Assessment by Occupational Physician (case by case) Fur Participate in Health Surveillance program, e.g. lung function test Handling animals Adhere to safe work instructions Box changing Reduce airborne allergens when cleaning cages, i.e. wet cleaning Disposal of soiled litter Use low dust bedding materials Changing filters of local exhaust ventilation or room ventilation Ensure adequate ventilation, e.g. local exhaust ventilation or work within a Class II Biosafety cabinet for specific procedures Washing cages. Reduce the frequency and time spent with animals in high density rooms 1 Although engineering controls can be useful in reducing exposure to animal allergens, airborne levels generated on direct contact to animals and bedding materials can still be significant. Respiratory protection of various types may be necessary to reduce exposure and must be fitted correctly. Advice on suitable and effective respiratory protection should be sought from OH&S. 9.5 ZOONOSIS All staff and students working with animals may be exposed to micro- organisms carried by the animals which may also be able to infect humans under the right conditions. These micro-organisms will be categorised into one of the risk groups as outlined in section 8.1. Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 12 of 27 Date of next review: 2018 19/11/15 • The passage of the micro-organisms may occur via scratches, bites, urine, faeces or through aerosols generated by further manipulation of tissue harvested from animals. • Information on zoonotic disease associated with animals commonly used at Monash University is found in Appendix I. • The appropriate animal husbandry skills in conjunction with using appropriate personal protective equipment will reduce the risk of cross infection. In addition, adopting standard PC2 precautions and restricting processes likely to create aerosols to biosafety cabinets will also reduce the risk of zoonotic infection. Further information and advice on zoonoses can be obtained from the OHS Health team. 9.6 INFECTIOUS ANIMAL MODELS The considerations outlined in section 9.3.2 also apply to research that involves the use of infectious animal models, where animals have been injected with infectious pathogens. Appropriate risk control measures must be in place prior to commencement and the OHS Health team can be contacted for advice. 10. HEALTH SURVEILLANCE Those staff and students working with animals or other biological agents may be subject to health surveillance which consists of the systematic monitoring of those “at risk” for any adverse effects of work on their health as it relates to their duties. It is delivered through medical assessment and biological monitoring (e.g. lung function testing). Staff working with animals may be subject to a pre-placement assessment to determine individual risk factors and baseline measurements. Further details of the Monash University Health surveillance program are outlined in the document ‘Health surveillance at Monash University', which is available at the OH&S website. 11. IMMUNISATION As part of their work or study, Monash University staff and students may be at risk of exposure to infectious diseases including those which are vaccine preventable. Staff and students should be offered such vaccines where the risk assessments demonstrate a need. The immunisation grid is available at the OH&S website and should be used to determine immunisation requirements. For further assistance contact the OHS Health team. 12. IMPORTATION OF BIOLOGICALS 12.1 QUARANTINE REQUIREMENTS All biological material brought into Australia directly by Monash staff is subject to quarantine requirements as set out in the Quarantine Act (1908) and Regulations. General information regarding the importation of biologicals is provided on the Department of Agriculturewebsite by following the Quarantine and Export service link or by contacting the Research office. 12.2 PURCHASE OF BIOLOGICALS • Before purchasing new biologicals, check with the Research Compliance officer regarding:Requirements for licenses, permits or notification to use the biologicals; • the physical containment (PC) requirements or Quarantine Approved Premise (QAP) classification for use and storage of the biological; Before purchasing new biologicals, check with your biosafety officer regarding: • the availability of appropriate handling conditions for the biological, e.g. Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 13 of 27 Date of next review: 2018 19/11/15 biological safety cabinets; 12.3 • the availability of appropriate emergency facilities and procedures required for the biological; • the appropriate waste disposal procedures required for the biological. PERMITS Before importing ANY biologicals from overseas Monash staff must obtain the appropriate importation permit through the Research Office. Staff should not apply for permits directly via DoA. 12.4 FACILITIES In certain circumstances DoA may require that all work to be conducted with specific imported biologicals must be performed within a QAP facility. Such facilities must be of a physical containment level specified by DoA and inspected and certified prior to the importation of biologicals. 13. GENETICALLY MODIFIED ORGANISMS 13.1 13.2 WORK/STUDY WITH GMO 13.1.1 All work/study utilising recombinant DNA technology is controlled through the Office of the Gene Technology Regulator. All Monash matters concerning gene technology are handled by the Research Office. More information can be obtained at http://www.monash.edu.au/researchoffice/biosafety/ 13.1.2 General information regarding the use of GMOs and appropriate approval can be obtained from the OGTR website (http://www.ogtr.gov.au) or by contacting the Research Office. FACILITIES 13.2.1 13.2.2 Facilities to be used for GMO work must comply with the requirements set out by the OGTR. • Facilities must be of the appropriate physical containment level matching the type of GMO dealing being conducted. • PC1, PC2 and PC3 facilities must meet the OGTR's guidelines for such facilities and be certified. • PC2 and PC3 facilities must be inspected annually by a person deemed competent by the Institutional Biosafety Committee (IBC) and PC3 facilities are also inspected routinely by the OGTR. No GMO work can commence until the appropriate approval has been sought and the facility where the work is to be conducted has been certified by the OGTR. 14. (M)SDS When purchasing biologicals, verify that the MSDS for the biological is already present in the university ChemWatch MSDS database, or as a hardcopy in the work area. If the MSDS is not already held, it must be requested from the supplier, manufacturer or importer. For purchases completed via SAP, a statement is already included in the order terms and conditions, which states: 14.1 HAZARDOUS MATERIAL Additional terms and conditions and material safety data sheets will be supplied for hazardous materials where this order specifies such hazardous materials. Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 14 of 27 Date of next review: 2018 19/11/15 A copy of all MSDS not currently held in the university ChemWatch MSDS database must be forwarded to ChemWatch to be included. 15. RISK MANAGEMENT Risk management must be completed on all processes/procedures/activities that involve biologicals and/or animals in accordance with the OHS Risk Management at Monash University procedure. 15.1 RISK MANAGEMENT MUST BE COMPLETED Before activities using biologicals and/or animals commence; 15.2 • before the introduction of new procedures, processes or equipment that use biologicals and/or animals; • when procedures or processes or equipment that use biologicals and/or animals are modified; • using the Monash Risk control program • by Facilities & Services staff before entering laboratory areas using the Safe Work Method Statement (SWMS) tool and in consultation with the local biosafety officer. UPDATE AND REVIEW OF RISK ASSESSMENTS 15.2.1 Risk assessments must be reviewed: • each time changes are made to the task, procedure; or equipment; or • at least every 3 years; 15.2.2 following an incident that involved the use of biologicals and/or animals. 15.2.3 Units/entities that undertake research using biologicals may need to update their risk assessments frequently, even daily, to ensure that their biological risk assessments are up to date. 16. SAFE WORK INSTRUCTIONS • Following the completion of risk assessments, safe work instructions must be developed and can be incorporated into laboratory procedures or safety manuals. Safe work instructions should include training, appropriate personal protective equipment, the need for immunisation and first aid and emergency procedures. • OH&S has developed Guidelines for the development of safe work instructions, to provide guidance and a template for use by areas which are available at the OH&S website. 17. TRAINING The training needs of staff and students should be determined using the OHS training at Monash University document and meet the requirements of OHS Induction & training at Monash University. 17.1 BIOLOGICAL SAFETY Training in the use of biologicals must be provided at a range of levels, including local and at university level. 17.2 LOCAL TRAINING Supervisors must ensure that induction and training in the use of biologicals is provided to staff and students under their supervision. This may be provided by Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 15 of 27 Date of next review: 2018 19/11/15 local safety personnel or experts with specific knowledge of the biologicals used in the area and must include: 17.3 17.4 • identification of biological hazards in the area and the nature of the hazard including exposure routes. • the location of risk assessments and safe work instructions for the biologicals held and used in the area; • the use and location of personal protective and emergency equipment for the use with biologicals; • local procedures, processes or equipment that use biologicals especially those resulting in the generation of aerosols. • immunisation requirements for working with biologicals. • biological waste handling, storage and disposal procedures UNIVERSITY LEVEL TRAINING • The Staff Development Unit (SDU) coordinates training courses on biological safety for staff and for Postgraduate and Honours students across all campuses and centres. • Information regarding the content and scheduling of training courses offered at Monash University is provided: • at the Staff Development Unit web site; and • in the OHS training at Monash University document. ANIMAL CARE AND USE The Information Session on “Regulatory Issues, Animal Care and Use in Research and Teaching at Monash University” is a prerequisite for Animal Ethics approval for Honours and Postgraduate students and inexperienced staff. Information about the course is available at the Monash Animal Ethics Office web site The following practical training courses in Animal Handling are run for Monash staff and students by Monash Animal Research Platform (MARP): • Mouse or Rat - Administration of Substances and Blood Collection • Rodent Anaesthesia • Surgical Techniques in Rodents Course information and dates are available from the MARP website Training in other species is available on request by contacting the MARP Training Manager. 17.5 TRAINING RECORDS In order for units/centres and supervisors to demonstrate effectively that they have provided local training for the staff and students that they supervise; local training records must be kept and this should: • include training in specific procedures • be maintained in a folder in each area where training is provided The student or staff member being trained should be able to demonstrate competence in the task/s before a record is completed. OH&S has a developed a proforma to use to record attendance at OHS training in each unit/entity, which is available at the OH&S web site. A short description of the points covered in the training should also be Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 16 of 27 Date of next review: 2018 19/11/15 documented for all biological training provided in the unit/entity. The description will act as both a reminder regarding the areas that should be covered in the training and as a record of the areas covered in the training. 18. WASTE DISPOSAL Correct biological waste management involves a structured program to ensure that any wastes generated are correctly identified in terms of their potential hazard to the environment and to any staff or students handling them. 18.1 ALL BIOLOGICAL WASTE MUST BE 18.1.1 handled by staff with knowledge and access to appropriate personal protective equipment; 18.1.2 segregated according to the particular hazards, treatment methods and recycling or re-use opportunities associated with the waste type, as outlined in the Biohazard Waste poster; 18.1.3 packaged to ensure that: 18.1.4 the waste materials cannot escape the container at any time; 18.1.5 containers used conform to the colour coding and marking system specified by Australian standards and outlined in Biohazardous waste collection and storage 18.1.6 are fit for transport; and 18.1.7 will not pose risks to personnel handling the wastes such as cleaning staff and waste disposal contractors 18.1.8 clearly labelled identifying: 18.1.9 the type of waste material; 18.1.10 the major contaminant or risk associated with the waste; 18.1.11 the academic/administrativeunit who generated the waste and their contact details, e.g. phone number; 18.1.12 date of generation; 18.1.13 In areas where Clinismart 64 bins are used: 18.1.14 the bins can be used without a bin-liner/bag in non-OGTR/QAP facilities. Proper segregation between sharps and non-sharps waste is still required. 18.1.15 only the G64 bins can be used for OGTR and/or QAP certified facilities and these must be used with a bin liner/bag, in accordance with the Guidelines for the Transport, Storage and Disposal of GMOs version 1.1(2011) for double-containing waste. The bin liner/bag must be tied off by a laboratory staff member and the lid locked into position prior to collection by the waste contractor 18.1.16 stored in a secure site/area specifically designated for the waste type and for the unit/entity generating the waste, refrigerated , if required. The waste store must be in compliance with EPA bunding guidelines to ensure spills will not cause pollution or pose an environmental hazard. 18.1.17 disposed of by a licensed EPA -prescribed waste contractor, however where appropriate waste may be autoclaved and disposed of to landfill in accordance with the Guidelines for the Transport, Storage and Disposal of GMOs version 1.1(2011), Sections 3.1.6 - 3.1.9 and AS/NZS 2243.3:2010, Section 10.6. 18.1.18 transported in such a manner to ensure that the health of staff, students, Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 17 of 27 Date of next review: 2018 19/11/15 visitors to the university, and/or the environment is not compromised and in accordance with Victorian EPA requirements and the Australian Dangerous Goods Code for the Transport of Dangerous Goods by Road and Rail . 18.1.19 There are specific procedures for the disposal of syringes, needles and syringe barrels. These are available in the document Syringes, Needles and Syringe Barrels – use & disposal, which is available at the OH&S website. 18.1.20 In any instance where the waste type is unclear or biological waste is contaminated with radiation, OH&S must be contacted for advice. 19. EMERGENCIES INVOLVING BIOLOGICALS AND ANIMALS 19.1 19.2 INCIDENT AND EMERGENCY RESPONSE • Emergency procedures for a biohazard spill are contained in the Monash ‘333’ emergency procedures booklet located near every telephone on all campuses. For off-campus locations, local emergency procedures must be followed. • Report all incidents to your supervisor, biosafety officer and safety officer using the Procedures for hazard and incident reporting, investigation and recording. • Incidents involving GMOs (including unintentional release into the environment) should also be immediately reported to the Research Compliance Officer (who will in turn notify the Institutional Biosafety Committee (IBC)). CRISIS MANAGEMENT • Monash University has invested considerable resources on planning crisis management and recovery. This planning includes consideration regarding crises involving biologicals. • Further details and the crisis management plan are located at the Crisis Management and Recovery web site http://www.adm.monash.edu.au/cmr/ 20. RECORDS Record to be kept by Academic/administrative unit Records Risk assessments To be kept for: 3 years OHS training records of local training provided by unit, including: • Attendees; • Short description of training content Research Office EPA waste disposal certificates Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 transport 7 years, or for as long as the staff member is employed 7 years PC2 training records 7 years or for as long as the staff member is employed OGTR dealings 5 years from when they become inactive PC2/PC3 lab inspection reports For the duration of validity of certificates Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 18 of 27 Date of next review: 2018 19/11/15 IBC minutes OHS training records, including: • Attendees • Short description of training content SDU OHS health team (confidential files) Indefinitely 7 years, or for as long as the staff member is employed Course evaluation sheets 2 years Health surveillance results 50 years Immunisation histories 50 years 21. REFERENCES 21.1 LEGISLATION Australian Dangerous Goods Code 7th edition Environment Protection Act 1970 Environment Protection (Industrial Waste Resource) Regulations 2009 (Vic) Quarantine Act 1908 Quarantine Regulations 2000 Occupational Health and Safety Act 2004 (Vic) Occupational Health and Safety Regulations 2007 (Vic) Gene Technology Act 2000 Gene Technology Regulations 2001 Guidelines for the Transport, Storage and Disposal of GMOs version 1.1, 2011 Prevention of Cruelty to Animals Act 1986 (Vic) Prevention of Cruelty to Animals Regulations 2008 (Vic) 21.2 MONASH UNIVERSITY OHS DOCUMENTS Guidelines for the development of safe work instructions Health surveillance procedure Immunisation procedure OHS Information Sheet – Syringes, needles & syringe barrels – use & disposal at Monash University Job Safety Analysis OHS risk management procedure Risk Control Program OHS induction and training at Monash University OH&S training course guide 21.3 AUSTRALIAN AND INTERNATIONAL STANDARDS OHSAS 18001:2007 Occupational Health & Safety Management Systems – Requirements AS/NZS 2982:1997 Laboratory design and construction Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 19 of 27 Date of next review: 2018 19/11/15 AS/NZS 2243.3:2010 Safety in laboratories Part 3: Microbiological aspects and containment facilities AS/NZS 3816:1998 Management of clinical and related wastes AS/NZS 4031:1992 Non-reusable containers for the collection of sharp medical items used in health care areas AS/NZS 1319:1994 Safety signs for the occupational environment 21.4 OTHER DOCUMENTS Guidance notes for the transport of Class 6.2 (infectious substances) dangerous goods (1997) Guidelines for the Transport, Storage and Disposal of GMOs, Version 1.1 (2011) Industry Code of Practice for the management of clinical and related wastes, 6th edition (2010) Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 20 of 27 Date of next review: 2018 19/11/15 22. DOCUMENT HISTORY Version number 3 3.1 4 Date of Issue Changes made to document November 2012 Using Biologicals and Animals at Monash University Procedure, v.3 Updated hyperlinks throughout to new OH&S website. 1. Updated Abbreviation for Department of Agriculture 2. Changed DAFF Biosecurity to Department of Agriculture (DoA) throughout the document 3. Updated Definitions section to only include those that are specific to this procedure. Provided link to Definitions tool. 4. Updated Specific Responsibilities section to include only those specific to this procedure. Provided link to “OHS Roles, Committees and Responsibilities procedure”. 5. Updated definition for Gene Technology (4.4) to reference Gene Technology Act (2000. 6. Updated references to legislation in Section 5.2. 7. Updated Sections 5.6 and 19.1 o reflect that Biosafety officers should report any breach of compliance to the Research Compliance Officer, who will in turn notify the Institutional Biosafety Committee (IBC). 8. Updated section 12 to clarify the roles of the Research Compliance Officer and local Biosafety officer regarding the purchase of biologicals. 9. Added requirements for the use of Clinismart bins in Section 18 – Waste disposal. 10. Updated records sections to reflect which records are retained by the Monash Research Office. July 2015 November 2015 Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 21 of 27 Date of next review: 2018 19/11/15 23. APPENDIX I - EXAMPLES OF ZOONOTIC DISEASES Host Disease in Humans Mode of transmission Sheep Brucellosis Direct contact with infected semen, foetuses, foetal membranes and vaginal secretions Sheep Q-fever Inhalation, direct contact with amniotic fluid or placenta Sheep Non-human primates Campylobacteriosis Ingestion Sheep Non-human primates Tuberculosis Inhalation, direct contact, ingestion Macaques Cercopithecine (B virus) encephalitis Direct contact, bite wounds Rodents, Farm and wild animals Leptospirosis Weil’s disease Direct contact, urine, contaminated soil and water Rodents Rabbits Sheep Farm animals Farm animals Rodents Amphibians Ringworm/Tapeworm Direct contact, soil may be a reservoir Salmonellosis Ingestion, Inhalation Direct contact Farm animals Rodents Amphibians Giardia/Parasitic infections Ingestion Direct contact Zebrafish Amphibians Aquarium water Bacterial/Protozoal infections Direct contact Ingestion Bats Australian Bat Lyssavirus Bites/scratches Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 22 of 27 Date of next review: 2018 19/11/15 24. APPENDIX II – RISK GROUP 2 ORGANISMS 24.1 EXAMPLES OF BACTERIA Abiotrophia spp. Acidovorax spp. Acinetobacter spp. Actinobacillus spp. Actinomyces pyogenes Aeromonas hydrophila Afipia spp. Arcanobacterium haemolyticum Bacillus cereus Bartonella henselae, B. quintana, B. vinsonii, B. elizabethiae, B. weisii Bordetella pertussis Brucella ovis Burkholderia spp. (except B. mallei and B. pseudomallei)† Campylobacter coli, C. fetus, C. jejuni Capnocytophaga canimorsus Chlamydia spp. (except avian strains of C. psittaci) Clostridium spp. (except those known to be nonpathogenic)† Corynebacterium diphtheriae†, C. renale, C. pseudotuberculosis Dermatophilus congolensis Edwardsiella tarda Eikenella corrodens Enterococcus spp. (Vancomycin-resistant strains) Erysipelothrix rhusiopathiae Pathogenic Escherichia coli (except Verocytotoxin-producing (VTEC) strains† and genetically crippled strains‡) Fusobacterium spp. Gardnerella vaginalis Gordona spp. Haemophilus influenzae, H. ducreyi Helicobacter pylori Kingella kingae Klebsiella spp. Legionella spp. Listeria spp.† Moraxella spp. Mycobacterium spp.† Mycoplasma pneumoniae, M. fermentans Neisseria gonorrhoeae, N. meningitidis† Nocardia spp. Oligella spp. Pasteurella spp. Rhodococcus equi Salmonella serovars† Shigella spp.† Sphaerophorus necrophorus Staphylococcus aureus Stenotrophomonas maltophilia Streptobacillus moniliformis Streptococcus pyogenes, S. pneumoniae Ureaplasma ureolyticum Vibrio cholerae, V. parahaemolyticus, V. vulnificus Yersinia spp. (except Y. pestis) Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 23 of 27 Date of next review: 2018 19/11/15 24.2 BACTERIA REQUIRING SPECIAL PRECAUTIONS Borrelia (mammalian) spp. Burkholderia pseudomallei Clostridium botulinum Clostridium tetani Corynebacterium diphtheriae Coxiella burnetii (smears and serology from samples) Escherichia coli Vero cytotoxin-producing strains, e.g. 0157, 0111 Leptospira interrogans (all serovars) Listeria monocytogenes Mycobacterium spp. other than M. tuberculosis complex Mycobacterium tuberculosis complex (except multi-drug resistant strains) Neisseria meningitidis (except for Serogroup B) Neisseria meningitidis (Serogroup B) Salmonella Typhi Shigella dysenteriae Type 1 Treponema pallidum Treponema pertenue 24.3 EXAMPLES OF PARASITES (INFECTIVE STAGES ONLY) Ancylostoma duodenale Ascaris lumbricoides Babesia divergens Babesia micro-organismsti Brugia spp. Cryptosporidium spp. Echinococcus spp. Entamoeba histolytica Giardia duodenalis (also known as Giardia lamblia and Giardia intestinalis) Hymenolepis diminuta Hymenolepis nana (human origin) Leishmania (mammalian) spp. Loa loa Naegleria fowleri Necator americanus Opisthorchis spp. (including Clonorchis sinensis) Plasmodium (human and simian) Strongyloides stercoralis Taenia saginata Taenia solium Toxocara canis Toxoplasma gondii Trichinella spiralis Trypanosoma brucei subspp. Trypanosoma cruzi Wuchereria bancrofti 24.4 EXAMPLES OF FUNGI Aspergillus fumigatus and A. flavus Candida albicans Cryptococcus neoformans Epidermophyton floccosum Micro-organismssporum spp. Sporothrix schenckii Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 24 of 27 Date of next review: 2018 19/11/15 24.5 EXAMPLES OF VIRUSES AND PRIONS Adenoviridae Adenovirus Arenaviridae Arenavirus Lymphocytic choriomeningitis (LCM) non-neurotropic strains Tacaribe virus complex Caliciviridae Feline calicivirus Norwalk-like Sapporo-like Largovirus Rabbit haemorrhagic disease Coronaviridae Coronavirus Flaviviridae Flavivirus Dengue 1, 2, 3 and 4 Japanese encephalitis (Nakayama strain) Kokobera Kunjin Murray Valley encephalitis Sarafend Saumarez Reef Yellow fever (strain 17D) Hepacivirus Hepatitis C Hepadnaviridae Duck hepatitis B Hepatitis B Herpesviridae Alphaherpesvirinae Simplex Varicella Betaherpesvirinae Cytomegalovirus Gammaherpesvirinae Herpes 6 and 7 Lymphocryptovirus (EB-like viruses) Orthomyxoviridae Influenza (except those in Table 3.10) Paramyxoviridae Paramyxovirinae Morbillivirus Measles Rubulavirus Menangle Mumps Newcastle disease virus (non-virulent endemic strains) Pneumovirus Respiratory syncytial virus Respirovirus Parainfluenza 1, 2, 3 and 4 Parvoviridae Human parvovirus Picornaviridae Encephalomyocarditis Encephalomyocarditis virus Enterovirus Coxsackie Echo Entero Parecho Polio 1, 2 and 3 Rhinovirus Hepatovirus Hepatitis A Poxviridae Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 25 of 27 Date of next review: 2018 19/11/15 Orthopoxvirus Vaccinia Parapoxvirus Orf Prions Reoviridae Gerstmann-Sträussler syndrome, Kuru and Creutzfeldt-Jakob agents (See Note 1 and Clause 3.5) Orbivirus Bluetongue viruses (endemic strains) Epizootic haemorrhagic disease viruses of deer (endemic strains) Rotavirus Rotavirus Retroviridae (serology, other tests on samples) Oncovirinae Human lymphotropic virus 1 Human lymphotropic virus 2 Lentivirinae Human immunodeficiency virus Togaviridae Alphavirus Barmah Forest Ross River Semliki Forest Arterivirus Equine viral arteritis Rubivirus Rubella Hepatitis D Hepatitis E Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 26 of 27 Date of next review: 2018 19/11/15 25. APPENDIX III – RISK GROUP 3 ORGANISMS 25.1 BACTERIA Bacillus anthracis Bartonella bacilliformis Burkholderia mallei Brucella spp. (except B. ovis) Chlamydia psittaci (avian strains) Coxiella burnetii (cultures, animal work and concentrates) Francisella tularensis (type A) Multi-drug resistant Mycobacterium tuberculosis complex Rickettsia spp. Yersinia pestis 25.2 FUNGI Aphanomyces astaci Blastomyces dermatitidis Ceratocystis ulmi Coccidioides immitis Histoplasma spp. Paracoccidioides brasiliensis Phytophthora cinnamomi 25.3 VIRUSES Arenaviridae Arenavirus Lymphochoriomeningitis (LCM) neurotropic strains Bunyaviridae Group C Oropouche Phlebovirus Hantavirus Hantaan and related viruses Flaviviridae Flavivirus Japanese encephalitis St Louis encephalitis Tick-borne viruses West Nile Yellow fever Paramyxoviridae Rubulavirus Mapuera Newcastle disease (exotic strains) Retroviridae (from cultures and concentrates) Oncovirinae Human lymphotropic virus 1 Human lymphotropic virus 2 Lentivirinae Human immunodeficiency virus Rhabdoviridae Lyssavirus Australian bat lyssavirus Rabies fixed strain (CVS II) Togaviridae Alphavirus Eastern equine encephalitis Western equine encephalitis Venezuelan equine encephalitis Using Biologicals & Animals Procedure, v4 Date of first issue: June 2006 Responsible Officer: Manager, OH&S Date of last review: November 2015 For the latest version of this document please go to: http://www.monash.edu.au/ohs/ Page 27 of 27 Date of next review: 2018 19/11/15